January 10, 2014—The Health Resources and Services Administration (HRSA) yesterday released the remaining two summaries of the 51 audits of 340B covered entities it performed in fiscal year 2012. HRSA’s latest update also includes brief descriptions of how some audits were resolved. Many of the audits are still not final, however.[ms-protect-content id=”2799″]
“The findings of the audits vary; some are fairly minor, requiring basic corrections of information in the 340B database,” the agency said in an update on the Office of Pharmacy Affairs (OPA) website. “Other audit findings include statutorily prohibited practices such as diversion of drugs obtained under 340B pricing, which places providers at risk of having to repay manufacturers. Depending on the finding, some covered entities are working with HRSA to develop a corrective action plan to ensure ongoing compliance.”
HRSA found no program violations in 19 of the 51 audits. In 16 audits, it required entities to make repayments of an unspecified dollar value to manufacturers. Within this latter group, six of the repayments appear to stem from findings that a single drug was improperly dispensed or administered to a single patient.
Two audits that were listed in HRSA’s last report in November as having sanctions “to be determined” appear in this latest version as having no sanctions.
HRSA said it is using the audit results to develop best practices for compliance with 340B requirements.[/ms-protect-content]